Lucideon Publishes New White Paper on USP Updates
Lucideon has published a new white paper on the updates made to the United States Pharmacopeia (USP) <231> limit test for heavy metals. Limit test <231> has been in place for over a century but will become obsolete on the 1st January 2018, being replaced by the updated USP <232> limit test. This white paper highlights some of the main implications of the updated test methods and heavy metal limits, as well as the advantages of implementing them early.
USP chapter <232> became official on the 1st December 2015. Companies can choose to implement the new chapter now or continue using USP <231> until 2018. Chapter <232> provides individual limits for heavy metal elements in pharmaceutical products and is accompanied by chapter <233> which details the test methods.
George Jones, Development Scientist, Chemistry, Lucideon, said:
“The new USP chapter <232> brings with it a number of changes that need to be considered by pharmaceutical companies. It really is advisable that they begin implementing the new methods and limit tests as early as possible to minimise disruption.”
“Heavy metal elements have been divided into classes for acceptable concentrations. The changes to these levels, and how they are tested for, could affect production, quality control and cleaning procedures, amongst other considerations.”
Lucideon is fully GMP certified for quality control testing of human and veterinary medicinal products. All Lucideon's services are undertaken in compliance with EU guidance on GMP as it applies to contract QC testing laboratories.
Lucideon is MHRA-inspected, and a UKAS accredited testing house (No. 0013), so you can trust that the test data that we provide to you is accurate and reliable. Our highly qualified and experienced technical staff use transparent, traceable, calibrated techniques and state-of-the-art equipment.
The white paper can be downloaded via the Resources panel on the right of this page.
19 May, 2016